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Senior Medical Writer – Clinical & Regulatory Medical Writing

Syneos Health
Syneos Health
3-5 years
Not Disclosed
Gurugram, India
2 May 11, 2026
Job Description
Job Type: Full Time Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Senior Medical Writer – Clinical & Regulatory Medical Writing

Company: Syneos Health
Job Title: Senior Medical Writer
Location: Gurugram, India
Work Model: Hybrid
Job ID: 25108453
Department: Clinical Solutions / Medical Writing


About the Role

Syneos Health is hiring a Senior Medical Writer for its clinical and regulatory writing team in Gurugram. This hybrid opportunity is ideal for professionals experienced in Medical Writing, Scientific Communication, Clinical Documentation, Regulatory Submissions, and Clinical Research Writing.

The selected candidate will lead end-to-end medical writing deliverables across clinical studies, regulatory submissions, scientific publications, and safety documentation while ensuring compliance with global regulatory standards and industry best practices.

This opportunity is best suited for candidates with 3–5 years of experience in Medical Writing within the biopharmaceutical, medical device, or CRO industry.


Key Responsibilities

Medical Writing & Scientific Documentation

  • Lead preparation and completion of medical writing deliverables
  • Ensure scientific content is presented clearly, accurately, and compliantly
  • Manage medical writing activities for clinical studies with minimal supervision
  • Coordinate writing deliverables across departments and project teams
  • Lead resolution of client comments and document revisions

Clinical & Regulatory Writing

Prepare and manage documentation including:

  • Clinical Study Protocols
  • Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Patient Narratives
  • Investigator Brochures
  • Informed Consent Forms (ICFs)
  • Plain Language Summaries
  • Periodic Safety Update Reports (PSURs)
  • Clinical Development Plans
  • IND Submissions
  • NDA & eCTD Submissions
  • Integrated Summary Reports
  • Journal Manuscripts
  • Scientific Abstracts, Posters, and Presentations

Regulatory Compliance & Quality Management

  • Ensure compliance with:
    • ICH E3 Guidelines
    • FDA Regulations
    • Good Publication Practices
    • Company SOPs and client standards
  • Coordinate editorial and quality review activities
  • Ensure proper source documentation management
  • Review documents for:
    • Scientific accuracy
    • Clarity
    • Consistency
    • Formatting compliance

Cross-Functional Collaboration

  • Collaborate with:
    • Biostatistics
    • Data Management
    • Regulatory Affairs
    • Medical Affairs teams
  • Review statistical analysis plans and table/figure/listing specifications
  • Provide recommendations to improve statistical outputs and document requirements
  • Build strong working relationships with internal teams and clients

Literature Research & Process Improvement

  • Conduct online clinical and scientific literature searches
  • Ensure compliance with publication and copyright standards
  • Identify process improvement opportunities and propose solutions
  • Contribute to internal capability development and process enhancement initiatives

Leadership & Mentorship

  • Mentor and guide junior medical writers on complex projects
  • Provide technical consultation and writing support to teams
  • Support departmental training and knowledge-sharing initiatives
  • Manage timelines, deliverables, and budgeted writing hours

Educational Qualification

Candidates with backgrounds in the following areas are preferred:

  • Life Sciences
  • Pharmacy
  • Medicine
  • Clinical Research
  • Biotechnology
  • Healthcare or related scientific disciplines

Required Experience

  • 3 to 5 years of relevant experience in:
    • Medical Writing
    • Scientific Writing
    • Regulatory Writing
    • Clinical Documentation
    • Clinical Research Communication

Industry Experience Required

Candidates should have prior experience within:

  • Biopharmaceutical Industry
  • Medical Device Industry
  • Contract Research Organizations (CROs)